Pilot Study to Asses the Function and Patency of Polyeste... | NCT00460291

Studies
Pilot Study to Asses the Function and Patency of Polyester-Coated Composite Bypasses From Autologous Varicose Veins

NCT00460291

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Oct 3, 2007Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Peripheral Arterial Disease
Peripheral Bypass Surgery
Bypass From Autologous Varicose Vein
External Graft Support

Interventions

Implantation of the ProVena vein graft during bypass surgery

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2005

Primary Completion Date

Not provided

Completion Date

Dec 2008Estimated

First Submitted Date

Apr 12, 2007

First Submission Date that Met QC Criteria

Apr 12, 2007

First Posted Date

Apr 13, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2007

Last Update Posted Date

Oct 3, 2007Estimated

Name	Class
B. Braun Melsungen AG	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

If patients need to undergo bypass surgery, either an autologous vein can be used as bypass or, if there are no suitable veins are available, a prosthetic graft can be implanted. Varicose veins normally are judged not to be suitable as bypass. The ProVena vein support, made from polyester, is considered to strengthen varicose veins so that they they become suitable as bypass. Thereby, the advantages of an autologous bypass and the stability of polyester material can be combined.

Patients that take part in the trial recieve an autologus bypass with a varicose vein, coated with ProVena. They are followed up at 3 and 6 months after implantation of a ProVena-coated bypass via duplex-sonography to assess the graft patency.

Detailed Description

The ProVena trial is a non-randomised multi-centre trial, aiming to assess the suitability of the ProVena vein support.

Currently, autologous veins are preferred to prosthetic grafts (Klinkert et al. 2004), but they are not considered to be suitable if they are varicose.

Some early data indicate that these veins can be used if an external support is applied (Moritz et al. 1993, 1992, Neufang et al. 2003). The proVena vein graft has been tested in animal experiments. All bypasses showed a reduced intima hyperplasia, no disadvantages were found. Nevertheless, as a ProVena-coated bypass cannot be regarded as completely autologus, it is necessary whether the coating does not increase the risk of

infections
scar formation, reducing the patency
higher incidence of seroma

ProVena is made from polyester filaments, similar to the material used for prosthetic grafts. As the material is used since years in peripheral bypass surgery, we do not expect increased risks.

It is planned to include 50 Patients in 10 centres. Patients can be included if they match the eligibility criteria, need to undergo peripheral bypass surgery and have varicose veins normally not suitable to form a bypass graft. If patients agree to take part and give informed consent, baseline data are collected and the surgery is protocolled. Patients are followed up after 3 ands six months by duplex sonography. The inflammation parameters are detected via analysis of a blood sample. Main endpoints and secondary endpoints are as follows:

Main endpoints:

Infection rate
primary patency
primary assisted patency
secondary patency

Secondary endpoints:

complication rate
occurence of bypass stenosis
time needed for preparation of the bypass vein
technical success i. e. successful implatation of the ProVena Graft

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Implantation of the ProVena vein graft during bypass surgery	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
infection rate
primary patency
primary assisted patency
secondary patency

Secondary Outcomes

Measure	Description	Time Frame
occurrence of complications
occurence of stenoses
time needed for preparation of the bypass vein

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged > 18 years 18 Jahre.
informed consent has been given and patients is complient to protocol
patient needs femoro-distal bypass surgery
only varicose ektatic veins are available
Bypass diameter > 5mm proximal and > 4mm distal.

Exclusion Criteria:

aged < 18 years
patient unable to take part in the follow-up
known sensibility to polyester
patient not expected to survive the next 12 months due to significant comorbidities
HIV-infection
Patient suffering from a floriding infection at the time of inclusion
infection or colonisation with MRSA
pregnancy
use of immunosuppresive drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Thomas Schmitz-Rixen, MD, PhD	Contact	+496963015349		schmitz-rixen@em.uni-frankfurt.de
Matthias Tenholt, MD	Contact	+496963015349		Matthias.Tenholt@kgu.de

Overall Officials

Name	Affiliation	Role
Thomas Schmitz-Rixen, MD, Professor	Johann Wolfgang Goethe University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité	Recruiting	Berlin		10117	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
15015183	Background	Klinkert P, Post PN, Breslau PJ, van Bockel JH. Saphenous vein versus PTFE for above-knee femoropopliteal bypass. A review of the literature. Eur J Vasc Endovasc Surg. 2004 Apr;27(4):357-62. doi: 10.1016/j.ejvs.2003.12.027.
8076087	Background	Moritz A, Grabenwoger F, Raderer F, Ptakovsky H, Magometschnigg H, Ullrich R, Staudacher M. Use of varicose veins as arterial bypass grafts. Cardiovasc Surg. 1993 Oct;1(5):508-12. doi: 10.1177/096721099300100508.

ID	Term
D050197	Atherosclerosis
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D016491	Peripheral Vascular Diseases